Qualification

Using tried and tested procedures, we are able to efficiently complete qualification activities which comply with customer requirements and current good manufacturing practice (GMP). This entails:

GMP risk analyses for DQ, IQ and OQ

Qualification plans for specific projects

Schedules and reports for factory acceptance testing (FAT) and/or site acceptance testing (SAT) in line with GMP requirements.

As we see it, the qualification requirements constitute integral parts of all steps of a project from the planning phase right through to the final start-up. This commences early on in the design phase, where GMP aspects are taken into account during planning and incorporated in the design qualification (DQ) documents. In the ensuing installation qualification (IQ) phase, a certificate is issued confirming that the installed equipment fully matches the customer requirements. Finally, the plant is started up in accordance with the defined tender specifications and profile of requirements which must be satisfied for operations qualification (OQ).

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